Catheter Securement Device Including Extended Anchor Pad and Release Liner Clasping Features

ABSTRACT

Embodiments disclosed herein are directed to a securement device including a retainer defining a channel and at least one mounting wing extending therefrom. The mounting wing extends distally of an insertion site a skin surface adjacent to the insertion site to prevent “rocking” or “pistoning.” The mounting wing further includes channels of reduced thickness configured to impart malleable properties on the mounting wing. This can allow the mounting wing to be shaped to fit different portions of the patient. The retainer further includes various locking and anti-rotational features to guide the catheter into position within the retainer and further prevent “rocking” or “pistoning.” The securement device also includes a protective pad to inhibit abrasions from a medical line, spin nuts, and the like, and includes a clasping feature to retain a portion of the release liner to prevent obstructing ingress/egress of the catheter.

PRIORITY

This application is a continuation of U.S. patent application Ser. No.16/851,031, filed Apr. 16, 2020, now U.S. Pat. No. 11,452,848, whichclaims the benefit of priority to U.S. Provisional Application No.62/835,312, filed Apr. 17, 2019, each of which is incorporated byreference in its entirety into this application.

SUMMARY

Briefly summarized, embodiments of the present invention are directed toa securement device configured to secure an external portion of amedical device, e.g. a catheter assembly, to a skin surface of apatient. The securement device includes a retainer that is employed tosecurely but removably retain an external portion of the catheterassembly in place. In one embodiment, the retainer is attached to ananchor pad such as an adhesive pad that adhesively attaches to the skinsurface. As used herein the securement device can also be referred toherein as a catheter retainer system or catheter retainer assembly.

In an embodiment, the retainer includes a body defining a channel and atleast one mounting wing, or footing, extending from the body. Themounting wing is configured to extend to, or distally of, the insertionsite to stabilize the insertion site and adjacent skin surface, relativeto the securement device and prevent rocking or pistoning. The mountingwing further includes channels configured to impart malleable propertieson the mounting wing so that the wing can be shaped to fit differentportions of the patient. The retainer further includes various lockingand anti-rotational to guide the catheter into position within theretainer and further prevent rocking or pistoning. The securement devicealso includes a protective pad to inhibit abrasions from a medical line,or the like, coupled to the catheter. The securement device furtherincludes a clasping feature to hold a liner in a retracted position toprevent obstructing ingress/egress of the catheter to/from the retainer.

Disclosed herein is a securement device for stabilizing an elongatemedical article on a skin surface of a patient including, a retainerhaving a retainer body defining a channel aligned with a central axis ofthe securement device, and configured to receive a portion of theelongate medical article, and a mounting wing supporting the retainerbody, an anchor pad supporting the mounting wing, including an adhesivelayer disposed on a portion of a lower surface of the anchor pad, anddefining an outer edge and an inner edge disposed laterally opposite theouter edge, and a release liner including a first portion disposed onthe adhesive layer and extending from the outer edge to the inner edge,and a second portion coupled to the first portion along the inner edgeand extending from the inner edge to the outer edge, the release linerincluding a clasping feature configured to releasably secure the secondportion to the first portion proximate the outer edge.

In some embodiments, the first portion is disposed between the secondportion and the adhesive layer, the second portion extends laterallyoutward from the outer edge to define a pull tab. The clasping featureincludes a flap die cut into the second portion and configured toreleasably secure the second portion to one of the first portion of therelease liner or the anchor pad. The clasping feature includes anaperture disposed in the first portion of the release liner, andconfigured to allow an upper surface of the second portion to contactthe adhesive layer, releasably securing the second portion thereto. Theanchor pad includes a fabric upper layer, and a central foam layerextending over a portion of the anchor pad and disposed between thefabric upper layer and the adhesive layer.

In some embodiments, the securement device further includes a protectivepad extending from a proximal edge of the anchor pad, aligned with thecentral axis of the securement device and disposed between the elongatemedical device and the skin surface of the patient. The protective padincludes a central foam layer and a release agent disposed on an uppersurface thereof, and wherein the protective pad is configured tomitigate abrasions to the skin surface caused by the elongate medicaldevice. The protective pad further includes a tear line dispose betweenthe protective pad and the anchor pad and configured to selectivelyrelease the protective pad from the anchor pad. The elongate medicaldevice is a midline catheter, a dialysis catheter, a Central VenousCatheter (“CVC”), a Peripherally Inserted Central Catheter (“PICC”), aPeripherally Inserted Venous catheters (“PIV”), a Foley catheter, aurinary catheter, a feeding tube, or a balloon catheter.

Also disclosed is a securement device for stabilizing an externalportion of a catheter assembly after insertion of an internal portion ofthe catheter assembly into a body of a patient via a catheter insertionsite, the securement device including, a retainer body defining achannel, a first mounting wing and a second mounting wing supporting theretainer body, a distal edge of the first mounting wing and the secondmounting wing extending distally beyond the catheter insertion site, afirst anchor pad and a second anchor pad, the first anchor padsupporting the first mounting wing, the second anchor pad supporting thesecond mounting wing, and a protective pad disposed proximally of thefirst anchor pad and the second anchor and disposed between the externalportion of the catheter assembly and a skin surface of the patient.

In some embodiments, the first mounting wing and the first anchor padadheres to a first portion of the skin, surface adjacent the insertionsite, and the second mounting wing and the second anchor pad adheres toa second portion of the skin surface adjacent the insertion site,opposite the skin surface first portion, the first mounting wing and thesecond mounting wing stabilizing the insertion site, disposedtherebetween, relative to the catheter assembly. One of the firstmounting wing or the second mounting wing includes a channel configuredto impart malleable characteristics on the mounting wing. A thickness ofthe mounting wing within the channel is between 0.010 in. and 0.020 in.The retainer body, the first mounting wing and the second mounting wingare configured to mitigate rocking or pistoning of the catheterassembly. A nose portion of the retainer body includes a cutaway portionconfigured to retain an anti-microbial disc between the nose portion andthe insertion site.

In some embodiments, the nose portion is configured to deflect a strainrelief of the catheter assembly at a predetermined angle and an axis ofthe external portion of the catheter assembly extends substantiallyparallel to the skin surface of the patient. The first mounting wing andthe second mounting wing are configured to receive the anti-microbialdisc therebetween. In some embodiments, the securement device furtherincludes an anti-rotation feature configured to inhibit rotation ofcatheter assembly relative to the retainer and to align the catheterassembly with the retainer. The anti-rotation feature includes one of apocket, alignment channel, or a locking window configured to engage oneof a nub, alignment ring, or locking tab disposed on the catheterassembly. The retainer body is formed of one of a transparent,translucent, or semi-translucent material, and is configured to allow aclinician to view a position of the catheter assembly therebelow. Theretainer body includes a viewing window communicating between thechannel and an outer surface thereof and configured to allow a user toobserve the external portion of the catheter assembly disposedtherebelow. The catheter assembly includes a colored portion configuredto align with the viewing window to indicate that the external portionof the catheter assembly is correctly aligned with the retainer body.The protective pad is configured to inhibit trauma to the skin surfacefrom the external portion of the catheter assembly.

Also disclosed is a method of securing a catheter assembly including,providing a securement device having, a retainer body defining a channelconfigured to receive at least a portion of the catheter assembly, amounting wing supporting the retainer body, an anchor pad coupled to themounting wing and including an adhesive layer disposed on a lowersurface thereof, and a release liner including a first portion disposedon the adhesive layer, and a second portion integrally formed with thefirst portion along a first edge and extending laterally outward to asecond edge, opposite the first edge, receiving the portion of thecatheter assembly within the channel, positioning a bottom surface ofthe securement device against a skin surface of a patient, urging thesecond portion laterally outward, peeling the release liner firstportion away from the adhesive layer from the first edge to the secondedge, and adhering the retainer to the skin surface of the patient.

In some embodiments, the release liner second portion further includes aclasping feature configured to releasably secure the release linersecond portion to the release line first portion proximate the secondedge. The clasping feature is a flap that is die cut into the releaseliner second portion. The clasping feature is an aperture disposed inthe release liner first portion that allows a portion of the adhesivelayer to contact the release liner second portion. The second portionextends laterally outward beyond the second edge to define a pull tab.In some embodiments, the method further includes positioning aprotective pad between a second portion of the catheter assembly and theskin surface of the patient, the protective pad extending proximallyfrom a proximal edge of the anchor pad and releasably coupled thereto.In some embodiments, the method further includes sliding ananti-microbial disc longitudinally proximally between a nose portion ofthe retainer body and a skin surface, the nose portion angled to impingeon the disc and retain the disc therebetween. In some embodiments, themethod further includes bending the mounting wing from a first positionto a second position, the mounting wing including a channel configuredto impart malleable characteristics so that the mounting wing remains inthe second position until repositioned.

These and other features of embodiments of the present invention willbecome more fully apparent from the following description and appendedclaims, or may be learned by the practice of embodiments of theinvention as set forth hereinafter.

DRAWINGS

A more particular description of the present disclosure will be renderedby reference to specific embodiments thereof that are illustrated in theappended drawings. It is appreciated that these drawings depict onlytypical embodiments of the invention and are therefore not to beconsidered limiting of its scope. Example embodiments of the inventionwill be described and explained with additional specificity and detailthrough the use of the accompanying drawings in which:

FIG. 1A shows a front perspective view of a catheter securement device,in accordance with embodiments disclosed herein.

FIG. 1B shows a rear perspective view of the catheter securement deviceof FIG. 1A, in accordance with embodiments disclosed herein.

FIG. 1C shows a plan view of the catheter securement device of FIG. 1A,in accordance with embodiments disclosed herein.

FIG. 1D shows a side-view of the securement device of FIG. 1A, inaccordance with embodiments disclosed herein.

FIG. 1E shows a side-view of the retainer of the securement device ofFIG. 1A, in accordance with embodiments disclosed herein.

FIG. 1F shows an exploded view the catheter securement device of FIG.1A, in accordance with embodiments disclosed herein.

FIG. 2A shows a perspective view of a retainer, in accordance withembodiments disclosed herein.

FIG. 2B shows a top-side plan view of a retainer, in accordance withembodiments disclosed herein.

FIG. 2C shows a rear side view of a retainer, in accordance withembodiments disclosed herein.

FIG. 2D shows close up detail of the retainer of FIG. 2C, in accordancewith embodiments disclosed herein.

FIG. 2E shows a side view of a retainer, in accordance with embodimentsdisclosed herein.

FIG. 2F shows an underside plan view of a retainer, in accordance withembodiments disclosed herein.

FIG. 2G shows a perspective view of a catheter securement deviceincluding a catheter disposed therein, in accordance with embodimentsdisclosed herein.

FIG. 2H shows an underside exploded view of a retainer including anchorpads and a catheter, in accordance with embodiments disclosed herein.

FIG. 3A shows a front perspective view of a catheter securement device,in accordance with embodiments disclosed herein.

FIG. 3B shows close up detail of an anchor pad of the cathetersecurement device of FIG. 3A, in accordance with embodiments disclosedherein.

FIG. 3C shows a plan view of the catheter securement device of FIG. 3A,in accordance with embodiments disclosed herein.

FIG. 3D shows an underside plan view the catheter securement device ofFIG. 3A, in accordance with embodiments disclosed herein.

FIG. 3E shows an underside view the catheter securement device of FIG.3A, in accordance with embodiments disclosed herein.

DETAILED DESCRIPTION

Reference will now be made to figures wherein like structures will beprovided with like reference designations. It is understood that thedrawings are diagrammatic and schematic representations of exemplaryembodiments of the present invention, and are neither limiting nornecessarily drawn to scale. It should also be understood that aparticular embodiment disclosed herein can have features that can bereadily separated from the particular embodiment and optionally combinedwith or substituted for features of any of a number of other embodimentsdisclosed herein.

Regarding terms used herein, it should also be understood the terms arefor the purpose of describing some particular embodiments, and the termsdo not limit the scope of the concepts provided herein. Ordinal numbers(e.g., first, second, third, etc.) are generally used to distinguish oridentify different features or steps in a group of features or steps,and do not supply a serial or numerical limitation. For example,“first,” “second,” and “third” features or steps need not necessarilyappear in that order, and the particular embodiments including suchfeatures or steps need not necessarily be limited to the three featuresor steps. Labels such as “left,” “right,” “top,” “bottom,” “front,”“back,” and the like are used for convenience and are not intended toimply, for example, any particular fixed location, orientation, ordirection. Instead, such labels are used to reflect, for example,relative location, orientation, or directions. Singular forms of “a,”“an,” and “the” include plural references unless the context clearlydictates otherwise. Also, the words “including,” “has,” and “having,” asused herein, including the claims, shall have the same meaning as theword “comprising.”

With respect to “proximal,” a “proximal portion” or a “proximal endportion” of, for example, a catheter disclosed herein includes a portionof the catheter intended to be near a clinician when the catheter isused on a patient. Likewise, a “proximal length” of, for example, thecatheter includes a length of the catheter intended to be near theclinician when the catheter is used on the patient. A “proximal end” of,for example, the catheter includes an end of the catheter intended to benear the clinician when the catheter is used on the patient. Theproximal portion, the proximal end portion, or the proximal length ofthe catheter can include the proximal end of the catheter; however, theproximal portion, the proximal end portion, or the proximal length ofthe catheter need not include the proximal end of the catheter. That is,unless context suggests otherwise, the proximal portion, the proximalend portion, or the proximal length of the catheter is not a terminalportion or terminal length of the catheter.

With respect to “distal,” a “distal portion” or a “distal end portion”of, for example, a catheter disclosed herein includes a portion of thecatheter intended to be near or in a patient when the catheter is usedon the patient. Likewise, a “distal length” of, for example, thecatheter includes a length of the catheter intended to be near or in thepatient when the catheter is used on the patient. A “distal end” of, forexample, the catheter includes an end of the catheter intended to benear or in the patient when the catheter is used on the patient. Thedistal portion, the distal end portion, or the distal length of thecatheter can include the distal end of the catheter; however, the distalportion, the distal end portion, or the distal length of the catheterneed not include the distal end of the catheter. That is, unless contextsuggests otherwise, the distal portion, the distal end portion, or thedistal length of the catheter is not a terminal portion or terminallength of the catheter.

To assist in the description of the securement system, the followingcoordinate terms are used (for example, see FIG. 1A). A “longitudinalaxis” is generally parallel to the axis of a channel of the retainer,through which the medical article extends. A “lateral axis” is normal tothe longitudinal axis. A “transverse axis” extends normal to both thelongitudinal and lateral axes. In addition, as used herein, “thelongitudinal direction” refers to a direction substantially parallel tothe longitudinal axis; “the lateral direction” refers to a directionsubstantially parallel to the lateral axis; and “the transversedirection” refers to a direction substantially parallel to thetransverse axis. The term “axial” as used herein refers to the axis ofthe channel, and therefore is substantially synonymous with the term“longitudinal” as used herein. As used herein, the terms “yaw,” “pitch,”and “roll” are used to in relation to movement, about a center point ofthe device, rotating about the transverse, lateral, and longitudinalaxes respectively.

Unless defined otherwise, all technical and scientific terms used hereinhave the same meaning as commonly understood by those of ordinary skillin the art.

Embodiments of the present invention are generally directed to asecurement device that is configured to secure an external portion of acatheter assembly to the skin surface of a patient after an internalportion of the catheter assembly has been placed in the patient toestablish vascular access, or for some other suitable purpose. Thesecurement device includes a catheter retainer that is employed tosecurely but removably retain the external portion of the catheterassembly in place. In one embodiment, the catheter retainer is attachedto an anchor pad, or base, such as an adhesive pad that adhesivelyattaches to the skin surface, to form the securement device, alsoreferred to herein as a catheter retainer system or catheter retainerassembly. It is appreciated that, though the discussion to followfocuses on a midline catheter, catheters and other tubular or elongatemedical devices that are configured for attachment or may be attached toa skin surface of the patient may also benefit from the teachingsherein, including dialysis catheters, Central Venous Catheter (“CVC”),Peripherally Inserted Central Catheter (“PICC”), Peripheral Intravenouscatheter (“PIV”), Foley and urinary catheters, feeding tubes, ballooncatheters, etc. In one embodiment, the catheter securement deviceincludes support wings, or mounting wings, which extend distally beyondthe insertion site to reduce rocking or pistoning of the catheter, bothinternally and externally of the insertion site. The mounting wings canfurther include channels to facilitate shaping of the support wing todifferent curvatures of a skin surface, depending on the location of thesecurement device. In an embodiment, a release liner disposed on a loweradhesive surface of the anchor pad includes clasping features thatsecure to lateral edges of the device. This prevents portions of therelease liner from obstructing ingress/egress of the catheter to/fromthe retainer. Embodiments herein further describe additional aspects ofthe catheter securement device.

FIGS. 1A-3E depict details of various embodiments of a cathetersecurement device (“securement device”) 100.

As shown in FIGS. 1A-1C, the securement device 100 can include an anchorpad 110, such as a left anchor pad 110A and a right anchor pad 110B, aprotective pad 110C, and a retainer 200. The retainer 200 can bedesigned to retain a portion of an elongate medical article, for examplea catheter system (“catheter”) 300, extension set, medical I.V. line,combinations thereof, or the like. The catheter system 300 generallycomprises a catheter hub 310, which supports an elongate catheter tube320 extending distally from the catheter hub 310. The catheter 300 canfurther include a strain relief portion 330 that further supports thecatheter tube 320. A proximal end of the catheter hub 310 can be coupledto a medical line, such as an extension set 70, using a spin nut 72,luer lock (not shown), or similar suitable connection. The catheter 300includes a lumen extending from a proximal end to a distal end, andprovides fluid communication between the medical line and a vasculatureof a patient.

In an embodiment, the anchor pad 110 comprises a central foam portion124 and a fabric overlap 126 and can include an adhesive layer disposedon a bottom surface thereof. The adhesive layer can be covered by aprotective release liner 130, for example a left release liner 130A anda right release liner 130B. Each release liner 130 can include a firstportion 132, a second portion 134, a pull tab 136, a clasping feature138, or combinations thereof, as described in more detail herein.

The retainer 200 includes a body portion 220 supported by at least onemounting wing 210, such as a left mounting wing 210A and a rightmounting wing 210B, as discussed in more detail herein. The body portion220 defines a central channel 230 that is designed to retain at least aportion of the elongate medical article, such as catheter hub 310,although it will be appreciated that any portion of the catheter 300,extension set 70, spin nut 72, combinations thereof, or the like, can beretained therein. The channel 230 can inhibit at least lateral andtransverse movement of the catheter hub 310, further the retainer 200can include one or more abutments, or the like, to inhibit longitudinalmovement of the catheter hub 310, relative to the device 100. Theretainer 200 can further include an elongate opening 232, extendinglongitudinally and communicating with the channel 230 to allowingress/egress of the catheter hub 310. As shown, e.g. FIG. 2H, theopening 232 can be disposed on an underside of the retainer, although inan embodiment the opening 232 can be disposed on a side surface or anupper surface of the retainer 200. In an embodiment, the retainer 200can further include various straps, latches, clasps, or the like tofurther secure the medical article within the retainer without departingfrom the spirit of the invention. In an embodiment, retainer 200 can beformed of a polycarbonate plastic, although other materials displayingsimilar suitable characteristics are also contemplated.

As shown for example in FIG. 1C, in an embodiment, a distal edge of themounting wing 210, anchor pad 110, or combinations thereof, extendsdistally of a catheter insertion point 80. As such, the left mountingwing 210A and the right mounting wing 210B, which are secured to theleft and right anchor pads 110A, 110B respectively, are secured to theskin surface that surrounds the insertion site 80. The mounting wings210A, 210B, thereby stabilize the insertion site 80, and surroundingskin surface 50 relative to the securement device 100 and prevent any“rocking” or “pistoning” of the catheter 300, as described in moredetail herein.

As shown in FIG. 1C, the configuration of the mounting wings 210provides little or no yaw movement 40 about the center point of thesecurement device 100 when the securement device is adhered to the skin.Further, the configurations of the mounting wings 210A, 201B providelittle or no yaw movement relative to each other. Similarly, as shown inFIG. 1D, the configuration of the mounting wings 210A, 210B, provideslittle or no pitch movement 42 of the securement device 100 when adheredto the skin. As such, the insertion site 80 secured between the leftmounting wing 210A and right mounting wing 210B is stabilized relativeto the securement device 100 and prevents the catheter from “rocking,”i.e. rotating about a center point of the securement device 100 aboutthe transverse axis (FIG. 1C) or about the lateral axis (FIG. 1D). Forexample, when a medical line, or the like, is attached to a catheter hub310 that is retained by the securement device 100, pressure is appliedas the clinician presses and twists a spin nut 72 into place. Thispressure can be a longitudinal distal force that causes the catheter topivot about the retainer body 220 through a horizontal plane and/orlongitudinally vertical plane. These forces can cause the catheter 300to move relative to the insertion site 80 causing kinking of thecatheter tube 320 either internally or externally of the insertion site80. Kinking of the catheter tube 320 can obstruct a fluid flowtherethrough and can cause discomfort to the patient.

Further, the configuration of the mounting wings 210 stabilizing theinsertion site 80 relative to the securement device 100 also prevents“pistoning” of the catheter 300. For example, as shown in FIG. 1E, theconfiguration of the mounting wings 210 prevents any movement ofcatheter along a longitudinal axis, relative to the insertion site 80.As such, the securement device prevents any “Z-kinking” of the cathetertube 320 caused by compression of the catheter tube 320 between theretainer 200 and the insertion site 80. Such kinking can disrupt fluidflow and cause discomfort, as described herein. In an embodiment, theconfiguration of the mounting wings 210A, 210B, prevents “pistoning”movement of the catheter tube 320 in and out of the insertion site 80.This prevents the introduction of microbes, bacteria, and the like, intothe insertion site 80, and mitigates infection.

As shown in FIGS. 1A-1D and 1F, in an embodiment and as discussed inmore detail herein, the retainer body 220 and mounting wings 210A, 210Bare configured to receive and retain an antimicrobial disc (“disc”) 60,for example a GuardIVa® Hemostatic pad, or similar anti-microbialhemostatic IV dressing. The disc 60 defines a substantially flattenedcylinder with a circular outer perimeter 64. The disc 60 can define asubstantially 1 inch diameter although greater or lesser dimensions arealso contemplated. The disc 60 includes a central aperture 66 extendingfrom a top surface to a bottom surface. The disc further includes a slit62 communicating between the outer perimeter 64 and the central aperture66. The slit 62 is configured to allow a portion of the catheter 300,e.g. catheter tube 320, strain relief 330, and the like, to passtherethrough to be received within the central aperture 66. The disc 60can be secured in place between a nose portion 222 of the retainer 200and the skin surface 50 of the patient. Further details of which can befound in U.S. 2017/0326340 which is incorporated by reference in itsentirety herein.

FIG. 1F depicts an exploded view of the catheter securement device 100,the catheter 300 and the antimicrobial disc 60. In an exemplary methodof use, a distal portion of a catheter 300 is inserted into a patient toaccess a vasculature thereof. The securement device 100, including theretainer 200, can then be lowered onto an external portion of thecatheter 300, e.g. the catheter hub 310 and strain relief 330, tostabilize the external portion against a skin surface of the patient.The protective pad 110C is positioned between the catheter hub 330 andthe skin surface of the patient to inhibit abrasions. The insertion site80 can be positioned between the distal portions of mounting wings 210to stabilize the insertions site 80, and surrounding skin, relative tothe securement device 100. The release liner 130 can then be removed bypulling on pull tab 136 in a lateral outward direction. Pulling the pulltab 136 as such peels the first portion 132 of the release liner 130away from a laterally inner edge and allows the adhesive layer 128 toadhere to a skin surface of the patient, as described in more detailherein. An anti-microbial disc 60 can then be positioned over theinsertion site 80 by sliding the disc 60 longitudinally and proximally.The portion of catheter tube 320 and strain relief 330, disposedexternally to the patient, can pass through the slit 66 and into thecentral aperture 66 and held in place by the nose portion 222 andmounting wings 210A, 210B.

FIGS. 2A-2H show various details of an exemplary retainer 200 of thesecurement device 100.

Mounting Wings

The retainer body 220 is supported by mounting wings 210, such as leftand right mounting wing 210A, 210B. For example, left mounting wing 210Ais coupled to a lower left portion of retainer body 220 and rightmounting wing 210B is coupled to a lower right portion of the retainerbody 220. Each of the mounting wings 210A, 210B extend laterally outwardand longitudinally distally from a central axis 90 of the retainer body220 so that, in an embodiment, a distal most portion of the mountingwing 210A, 210B extends beyond a distal end of the retainer body 220. Inan embodiment, as shown in FIG. 2B, each of the mounting wings 210A,210B can define a curved outer perimeter, or “footprint,” when viewedfrom a plan view. It will be appreciated however that the shape of theouter perimeter of the mounting wings 210, can include angular, orvarious other shapes, and still fall within the scope of the presentinvention. Further, as shown in FIG. 2B, mounting wing 210A issubstantially a “mirror image” shape of mounting wing 210B. However, inan embodiment, the left and right mounting wings 210A, 210B can beasymmetrical, i.e. of differing size and shape from each other.

Each of the left and right mounting wings 210A, 210B are coupled with aleft and right anchor pads 110A, 110B, respectively. In an embodiment,at least a portion of the lower surface of the mounting wing 210 isattached to an upper surface of the anchor pad 110. The mounting wings210 can be coupled to the anchor pads 110 using adhesive, bonding,welding, or similar suitable techniques. As shown for example in FIGS.1A, 2H, 3C-3D, anchor pads 110A, 110B are in a laterally spaced apartrelationship to allow ingress/egress of the medical articletherebetween, by way of an underside of the device 100. In anembodiment, left and right anchor pads 110A, 110B can be formedintegrally, so as to form a single anchor pad 110. For example, whereingress/egress of the medical article to/from the retainer 200 is by wayof an upper side thereof, a single anchor pad 110 can be provided.

Channels

As shown in FIGS. 2B-2C, in an embodiment, the mounting wings 210 caninclude a channel 212, for example a left channel 212A and a rightchannel 212B. The channel 212 extends longitudinally and can define aliving hinge. The channel 212 extends from a proximal edge to a distaledge of the mounting wing and is laterally offset from a central axis 90of the device 100. In an embodiment, the longitudinal axis of thechannel 212 substantially aligns with an inner edge of the anchor pad110, however other lateral positions on the mounting wing 210 are alsocontemplated.

In an embodiment, the channels 212 are dimensioned so as to allow themounting wings 210 to be shaped to a predetermined angle and remain inplace, thus imparting malleable characteristics on the mounting wings210. As mentioned, the retainer 200 can be formed of a polycarbonateplastic. Channels 212, formed in the mounting wings 210, provide aportion of the wing that is of a reduced thickness. The reducedthickness of the mounting wing can reduce the elasticity of the mountingwing, to provide more malleable characteristics. This allows the wing tobe shaped through a laterally vertical plane to a predetermined angleand remain at the predetermined angle until reshaped. As used herein,elastic characteristics are where the wing can deform when a force isapplied and then return to its original shape when the force is removed.By contrast, malleable characteristics includes deformation when a forceis applied but remain in the deformed shape when the force is removed.

In an embodiment, a thickness of the wing 210 within the channel 212,i.e. thickness (x), can be between 0.005 in. and 0.035 in. In anembodiment, the thickness (x) of the wing 210 within the channel 212 canbe between 0.010 in. and 0.020 in. The thickness (x) is sufficient toreduce the elasticity of the wing to impart malleable characteristics onthe mounting wing 210. Further, the thickness (x) is sufficient tomaintain the position of the wing once shaped to a desired angle. In anembodiment, the channel 212 defines a V-shape or a U-shape crosssection, although other cross-sectional shapes are also contemplated. Inan embodiment, the lateral width and/or longitudinal length of thechannels 212 can also vary to provide desired malleable characteristics.In an embodiment, the retainer is formed of a transparent or translucentpolycarbonate material, as the mounting wing including the channel 212is positioned from a first position to a second position, thepolycarbonate material can yield and can turn white to indicate the winghas been shaped. In an embodiment, the malleable properties of thechannel allows the mounting wing 210 to remain in the second positionuntil repositioned.

In an embodiment, the mounting wing 210 can include more than onechannel 212. As shown in FIG. 2D, in an embodiment, a first left channel212A is defined in an upper surface of the mounting wing 210, and asecond left channel 212C is defined in a lower surface of the mountingwing 210. In an embodiment, a channel 212A on the upper surface and achannel 212C on the lower surface can be laterally aligned. In anembodiment, a channel 212A on the upper surface and a channel 212C onthe lower surface can be laterally offset.

In an embodiment, as shown in FIG. 2B, a channel 214 only partiallytransects the mounting wing 210. For example, channel 214A extendsdistally from proximal edge of the mounting wing 210 to a point that isproximal of a distal edge of the mounting wing 210. Similarly, channel214B extends proximally from distal edge of the mounting wing 210 to apoint that is distal of a proximal edge. Channel 214C extends through amid-point of the mounting wing. Varying numbers and combinations ofchannels 214A-214C can provide a “lattice” of channels. Further, varyingnumbers and combinations of channels 212A-212C, 214A-214C, combinationsthereof, or the like can provide differing malleable characteristics ofthe mounting wing 210.

Advantageously, the channels 212 can allow the mounting wing 210 to beshaped to match the differing curvatures of the patients' skin surface.Notably, the mounting wing 210 can be shaped, and remain in that shapeonce applied to the skin surface. By contrast, mounting wings withoutthe channels 212 elastically return to their original shape, i.e.substantially flat, thereby distorting the skin surface to which theyare adhered to. Moreover, the channels 212 allow the same device to beused in a range of situations, positions on the body, or types ofpatient. For example a wrist portion of a child defines a more acuteradius of curvature than that of an adult leg. Alternatively, the skinof the elderly is more delicate and deforms more readily. Accordingly,channels 212 allow the device 100 to fit comfortably to different areasof the patient and accommodate these variations.

Nose Griping and Deflection

In an embodiment, as shown in FIGS. 1E, 2E-2F, the retainer body 220further includes a nose portion (“nose”) 222.

As shown in FIGS. 2A and 2E, in an embodiment, the nose portion 222defines a “cutaway” recess 224, extending transversely between the nose222 and a skin surface and extending laterally between the left mountingwing 210A and the right mounting wing 210B. The recess 224 is configuredto receive an anti-microbial disc 60. Worded differently, the retainer200 including the recess 224 can be configured to retain and stabilize aportion of the catheter 300 without disturbing an anti-microbial disc 60disposed at the insertion site 80. In an embodiment, the nose portion222 can be angled downward and configured to impinge against theantimicrobial disc 60 to retain the disc 60 in an interference fitbetween the nose 222 and the skin surface. Advantageously, the retainer200 can secure the disc 60 in place and allow a clinician to change outdisc 60 as needed without disturbing the securement device 100, catheter300 or the like.

In an embodiment, the angled nose portion 222 can be configured toconstrain the catheter strain relief 330 and deflect it in a slightlydownward direction. As shown in FIG. 1E, the angle (θ) of the downwardbend imposed by the nose 222 is predetermined and can vary according tovarious factors. The angle of the nose 222 also allows the catheter hub310 to be positioned substantially parallel to the skin surface 50.Advantageously, with the catheter hub 310 positioned substantially flatagainst the skin surface of the patient, this further stabilizes thatcatheter hub 310 relative to the skin surface and prevents rocking,pistoning, or cantilevering, of the catheter, as described herein.Further, with the catheter hub 310, and associated extension sets, etc.aligned parallel with a skin surface, this provides a lower profile andprevents the hub 310 from protruding from the skin surface and catchingon items of clothing, bandages, or the like. Further details ofexemplary retainers and associated structures can be found in U.S. Pat.Nos. 7,014,627 and 8,740,852, and U.S. Publication No. 2017/0326340,each of which is incorporated by reference in its entirety into thisapplication.

Catheter Hub Rotation Prevention

As shown in FIGS. 2F-2H, the retainer 200 can include one or moreanti-rotation features that inhibits rotation or “roll” of the catheter300 about the longitudinal axis. In an embodiment, the retainer 200 caninclude a pocket 228, for example a left pocket 228A and a right pocket228B, which can be configured to receive a nub 349, for example a leftnub 228A and a right nub 228B, disposed on the catheter 300. The nub 349can be a protrusion that extends perpendicularly to the longitudinalaxis and engages the pocket 228 to inhibit rotational movement of thecatheter 300, relative to the retainer 200, about the longitudinal axis.In an embodiment, the nubs 349 can engage the pockets 228 in a snap-fit,interference-fit, press-fit, or similar engagement to secure thecatheter 300 within the retainer 200. In an embodiment, the retainer 200further includes an alignment channel 236 configured to receive analignment ring 350 disposed on the catheter 300. In an embodiment thealignment ring 350 can be disposed annularly about the catheter hub 330.The alignment channel 236 can be configured the receive the alignmentring 350 to ensure the catheter 300 is correctly seated within theretainer 200, and to inhibit longitudinal movement of the catheter 300relative to the retainer 200.

In an embodiment, the retainer 200 further includes a lock window 234configured to receive a lock tab 352 extending from the catheter 300. Inan embodiment, the lock tab 352 extends from the catheter hub 310,perpendicular to a longitudinal axis of the catheter 300. The lockingtab 352 can engage the locking window 234 to inhibit movement of thecatheter 300 relative to the retainer 200, for example rotationalmovement, lateral movement, longitudinal movement, combinations thereof,and the like. Advantageously, the one or more anti-rotation featuressuch as the nubs 349, pockets 228, locking tab 352, locking window 234,alignment ring 350 and alignment channel 236 can inhibit movement of thecatheter 300, to further reduce rocking, pistoning, and/or kinking ofthe catheter tube 320. Further, the one or more anti-rotation featurescan allow a clinician to determine that the catheter 300 is correctlyseated within the retainer 200 without visual confirmation, i.e. bytactile confirmation. Advantageously, this can expedite correctplacement of the catheter 300 within the securement device 100.

In an embodiment, the lock tab 352 can include a different color fromthat of the retainer 200, catheter assembly 300, or the like so as toprovide easy visual confirmation to a clinician when the catheter 300 iscorrectly seated within the retainer 200. As shown in FIG. 2G, in anembodiment, the retainer 200 can be formed of a transparent,translucent, or semi-translucent material to allow a clinician to viewthe position of the catheter 300, disposed therebelow, relative to theretainer 200. This can facilitate positioning the catheter 300 relativeto the retainer 200. In an embodiment, the retainer 200 can include aviewing window 238, or aperture, communicating between the channel 230and an outer surface of the retainer 200 to allow a clinician to observethe catheter 300 disposed therebelow. In an embodiment, a coloredportion of the catheter 300 can align with the viewing window 238 toindicate that the catheter 300 is correctly seated within the retainer200. Advantageously, this can expedite correct placement of the catheter300 within the securement device 100.

Advantageously, one or more anti-rotation features described hereinallow a user to attach or detach medical lines, syringes, extensionsets, and the like to/from the catheter hub 310 with only one hand.Often the connectors that couple to the catheter hub 310 require somesort of twisting motion to fully engage or disengage therefrom.Typically a clinician would require one hand to stabilize the catheterwhile attaching/detaching the catheter hub with the other. Embodimentsdisclosed herein stabilize the catheter 300 and allow a user toattach/detach items to/from the catheter hub single handedly.

Anchor Pad

FIGS. 3A-3E show various details of the anchor pad 110 and associatedstructures. As shown in FIGS. 3A-3B, the anchor pad(s) 110 can be formedof one or more layers of material. For example, the anchor pad 110 canbe formed of a foam portion 124 and can include an overlying fabricportion 126 such as polyester fiber, medical gauze, or the like. Anadhesive layer 128 can be applied on a bottom, skin-facing, surface ofthe anchor pad 110 to allow the securement device 100 to adhere to askin surface 50 of a patient. In an embodiment, the foam layer 124 canextend over a portion of the anchor pad 100. In an embodiment, thefabric portion 126 can extend over a portion of the anchor pad 110. Inan embodiment, the adhesive layer 128 can extend over a portion of theanchor pad. A release liner 130 can be disposed on the adhesive layer128 to protect the adhesive layer 128 during handling and transport.

In an embodiment, as shown in FIG. 3A, 3C, an outer perimeter 122 of theanchor pad 110 can be defined by the fabric portion 126, with the foamportion 124, extending over only a portion of the anchor pad 110. Theadhesive layer 128 can extend over a lower surface of the fabric layer126, foam layer 124, or combinations thereof. Optionally, the outerperimeter 122 of the anchor pad 110 can be defined by the foam portion124 with the fabric portion 126, extending over a portion of the anchorpad 110.

In an embodiment, the mounting wing 210 can be disposed on an uppersurface of the anchor pad 110 and secured thereto. In an embodiment, themounting wing 210 can be disposed between one or more layers that formthe anchor pad 110 and secured therebetween. For example, a portion ofthe mounting wing 210 can be disposed between the fabric layer 126 andthe foam layer 124, or between the foam layer and the adhesive layer128. As such, the mounting wing 210 can be attached to the anchor pad110 on both an upper surface and a lower surface of the mounting wing210. This further secures the mounting wing 210 to the anchor pad 110.These and other combinations of anchor pad construction are contemplatedto fall within the scope of the present invention.

In an embodiment, the anchor pad 110 includes a scalloped portion 116,for example a left scalloped portion 116A and a right scalloped portion116B. The scalloped portion 116 can be configured to match a radius ofcurvature of the antimicrobial disc 60, and/or a portion of the mountingwing 210. The disc 60 can then be received between the scallopedportions 116A, 116B of the anchor pads 110A, 110B respectively tocontact the skin surrounding the insertion site 80.

Protective Pad

As shown in FIGS. 3A, 3C-3D, in an embodiment, the securement device 100further includes a protective pad 110C. The protective pad 110C can beintegrally formed with either of a left anchor pad 110A or a rightanchor pad 110B, or both. In an embodiment, the protective pad 110C canbe a separate structure from that of anchor pads 110A, 110B. Theprotective pad 110C can be formed of similar materials to the anchor pad110, as discussed herein. For example, the protective pad 110C can beformed of a foam material. In an embodiment, the protective pad 110C caninclude an adhesive layer disposed on at least a portion of a lowersurface thereof. In an embodiment, the thickness of the protective pad110C can be the same as the anchor pads 110A, 110B. In an embodiment,the thickness of the protective pad 110C can be different from theanchor pads 110A, 110B. In an embodiment, the protective pad 110C isthicker than anchor pads 110A, 110B so as to provide increasedcushioning between the patients skin and the catheter 300, extension set70, retainer 200, or combinations thereof.

In an embodiment, as shown in FIGS. 3C-3D, the protective pad 110C isremovably attached to either of the left or right anchor pad 110A, 110B.As shown in FIGS. 3C-3D, the protective pad 110C can include a tear line118 to facilitate detachment of the protective pad 110C from the anchorpad 110. In an embodiment the protective pad 110C and anchor pad 110 canbe integrally formed and a tear line 118, such as a perforation, scoreline, laser cut line, or the like, can be formed therein. In anembodiment, the protective pad 110C and anchor pad 110 can be formed asseparate structures and attached thereto along tear line 118 usingadhesive, bonding, welding, or similar suitable techniques thatfacilitate detachment along the tear line 118.

In an embodiment, a laterally central axis of the protective pad 110Csubstantially aligns with the laterally central axis 90 of the device100. The protective pad 110C extends proximally from a proximal edge 112of the anchor pads 110A, 110B. In an embodiment, the protective pad 110Cextends to a point that is proximal of the spin nut 72. The protectivepad 110C can also extend laterally from a central axis to a lateral edgeof the catheter 300. In an embodiment, the protective pad 110C extendsto an outer-most lateral edge of the spin nut 72. In an embodiment theprotective pad 110C extends beyond an outer-most lateral edge of thecatheter 300, extension set 70, spin nut 72 or combinations thereof, sothat a width of the protective pad 110C is greater than a width of themedical article. The protective pad 110C can be positioned so that it issubstantially below the connection of the extension set 70 with thecatheter 300.

Advantageously, the protective pad 110C protects the patients' skin fromabrasions, pressure ulcers, or the like, caused by the retainer 200,extension set 70, spin nut 72, or luer lock, etc. For example, the spinnut 72 often includes protrusions or ribs to facilitate grip, howeverthese protrusions can cause pressure ulcers when pressed or rubbeddirectly against the patients' skin. It will be appreciated that otherportions of the extension set 70, catheter hub 310, retainer 200, orconnecting portions therebetween can also include protrusions, edges, orthe like that can cause similar problems for the patient. Accordingly,the protective pad 110C protects the patients' skin from such trauma.Further, the protective pad 110C can be easily detached should the padbe unnecessary or obstruct the medical article.

The protective pad 110C can further include release agent disposed on atleast a portion of an upper surface thereof. In an embodiment, therelease agent can be formed as a layer disposed on an upper surface orcan be integrated with the material forming the protective pad 110C. Therelease agent can prevent an adhesive from sticking to an upper surfaceof the protective pad 110C. For example, portions the securement device100 can be covered by a polyurethane dressing to provide a barrier andprevent infection. Such dressings often include an adhesive lowersurface for adhering to the device, catheter, associated structures, anda skin surface of the patient. When such a dressing is removed, therelease agent prevents the dressing from adhering to the upper surfaceof the protective pad 110C. This in turn prevents portion of the medicalarticle, disposed between the dressing and protective pad, from beingdisturbed as the dressing is removed, thereby avoiding patientdiscomfort, dislodgment of the catheter, disruption of fluid flow, orthe like.

Release Liner

Referring to FIGS. 3A-3E, in an embodiment, the anchor pad 110 includesa release liner 130 disposed on a lower surface thereof. For example, aleft release liner 130A and a right release liner 130B are disposed on alower surface of the left anchor pad 110A and right anchor pad 110B,respectively. In an embodiment, each of the release liners 130A, 130Bincludes a first portion 132 and a second portion 134. The first portion132 extends laterally from an outer edge 144 of the anchor pad 110towards a central axis 90 of the device 100, to a lateral inner edge 142of the anchor pad. In an embodiment, the first portion 132 defines anouter perimeter shape which can be similar to an outer perimeter shapeof the anchor pad 110 so as to cover an entire lower surface of theanchor pad 110 and any adhesive layer disposed thereon. In anembodiment, the outer perimeter of the first portion 132 extends beyondthe outer perimeter of the anchor pad 110 along at least one edge. Assuch, the release liner 130 also protects an edge surface of the anchorpad, and any adhesive layers disposed thereon. For example, as shown inFIG. 3C, a first portion 132B of the right release liner 130B defines anouter perimeter shape that is similar to the outer perimeter shape ofthe right anchor pad 110B, further a right side perimeter of the firstportion 132B also extends laterally beyond an outer perimeter 116 of theanchor pad 110 so as to protect a side surface thereof.

In an embodiment, the first and second portions 132, 134 of the releaseliner 130 are attached along a join line disposed along a lateral inneredge 142 of the anchor pad 110. In an embodiment the join line extendsalong an edge of the release liner that is proximate the central axis90, although other edges of the release liner 130 are also contemplatedand fall within the scope of the present invention. In an embodiment,first and second portions 132, 134 are formed separately and attachedalong the join line using adhesive, bonding, welding, mechanicalfasteners, or similar suitable attachments. In an embodiment, first andsecond portions 132, 134 are formed as a single monolithic piece 130 anda join line 142 is formed therein by folding, scoring, perforation,laser cutting, or similar suitable methods.

In an embodiment, the second portion 134 extends from the join line,disposed along the lateral inner edge 142 to a lateral outer edge 144 ofthe anchor pad 110. In an embodiment, the second portion 134 extendslaterally beyond the lateral outer edge 144 of the anchor pad 110. Forexample, as shown in FIG. 3C, the second portion 134B of the rightrelease liner 130B extends laterally from the join line, disposed at thelateral inner edge 142B, to a point disposed laterally beyond a lateralouter edge 144B of the anchor pad 110B. In an embodiment, the secondportion 134 can define a similar outer perimeter shape to the firstportion 132 such that when the two portions are attached and foldedagainst each other, along the join line, the first and second portions132, 134 define a substantially similar outer perimeter shape. In anembodiment, the first and second portions 132, 134 can define differentouter perimeter shapes. In an embodiment, the second portion 134 canextend from the lateral inner edge 142, beyond the lateral outer edge144, to provide a pull tab 136, e.g. right pull tab 136B. In anembodiment, pull tab 136 can be formed integrally with the secondportion 134, as a single monolithic piece and formed of the samematerial. In an embodiment, the pull tab 136 can be a separate structurefrom that second portion 134 and coupled thereto using adhesive,bonding, welding, or similar suitable attachment means. As such, thepull tab 136 can be formed of a different material from that of therelease liner 130, and can provide differing properties, such as adifferent color, texture, or mechanical properties.

Clasping Feature

As shown in FIGS. 1A-1B, 3C-3E, in an embodiment, the release liner 130includes a clasping feature 138 located adjacent a lateral outer edge144 of the anchor pad 110. The clasping feature 138 can be configured tomaintain the second portion 134, pull tab 136, or combinations thereofin a predetermined position that is accessible to the user and preventsthe second portion 134 from obstructing the opening 232 of the channel230. In an embodiment, the clasping feature 138 can releasably attachthe second portion 134 to the lateral outer edge 144 of the anchor pad110, to a lateral outer edge of the first portion 132, or combinationsthereof. In an embodiment, the clasping feature 138 can be a flapattached to the second portion 134, and can extend toward the centralaxis 90. In an embodiment, the clasping feature 138 can be formed as aseparate structure from the second portion 134 and attached theretousing adhesive, bonding, welding, or similar suitable attachment means.

As shown in FIG. 3D, the clasping feature 138 can be a U-shaped cutformed in a portion of the release liner 130. It will be appreciatedthat other shapes and sizes of flap are also contemplated and fallwithin the scope of the present invention. In an embodiment the flap ofthe clasping feature 138 is formed integrally with the second portion138 by forming a substantially U-shaped die cut flap in the secondportion 134 of the release liner.

As shown in FIG. 3E, in an embodiment, the clasping feature 138 isformed as an aperture 140 in the release liner first portion 132. Forexample, the clasping feature 138A includes an aperture 140A disposed inthe left release liner first portion 132A. The aperture exposes aportion of the adhesive layer 128, disposed on an underside of theanchor pad 110A. The release liner second portion 134B can fold backover the aperture 140A, as described herein. A surface of the secondportion 134A can then adhere to the portion of adhesive layer 128 of theanchor pad 110A, releasably attaching the second portion 134A thereto.In an embodiment, the clasping feature 138 can include an adhesive spotdisposed between the first and second portions 132, 134 of the releaseliner.

Embodiments of the clasping feature 138, as described herein can holdthe second portion 134 adjacent the first portion 132 and anchor pad110. This keeps the second portion 134 from protruding downwards fromthe device, snagging on objects and obstructing a lower, longitudinalopening 232. For example, as shown in FIGS. 1A-1B, 2H, embodiments ofthe clasping feature 138 hold the second portion 134 substantially flatagainst first portion 132, providing a clear entryway for theingress/egress of a medical article to the retainer 200 of the device.

Method of Use

In an exemplary method of use, a catheter securement device 100 isprovided including a retainer 200, an anchor pad 110 and a release liner130, as described herein. A distal portion of a catheter 300 can beinserted into a vasculature of a patient. An external portion of thecatheter 300 can then be retained and stabilized by the securementdevice 100. As the device 100 is lowered on to the catheter externalportion, the release liner second portion 134 is maintained in asubstantially horizontal orientation and prevented from obstructing theopening 232 by the clasping feature 138. The clasping feature 138 alsomaintains the position of the pull tab 138 as extending laterally beyondthe release liner first portion and anchor pad 110.

With the securement device 100 situated correctly on a skin surface ofthe patient, the clinician is able to grasp the pull tab 136 and urgethe release liner second portion 134 laterally outward. This causes theclasping feature 138 to detach from the release liner first portion132/anchor pad 110. The second portion 134, which is also attached tothe first portion 132 at a join line at a lateral inner edge 142, peelsthe first portion away from the anchor pad 110 from the lateral inneredge 142 towards the lateral outer edge 144, exposing an adhesive layerto the skin surface of the patient. Each of the left and right anchorpads can be adhered to the skin of the patient in a sequential manner.

Embodiments of the invention may be embodied in other specific formswithout departing from the spirit of the present disclosure. Thedescribed embodiments are to be considered in all respects only asillustrative, not restrictive. The scope of the embodiments is,therefore, indicated by the appended claims rather than by the foregoingdescription. All changes that come within the meaning and range ofequivalency of the claims are to be embraced within their scope.

What is claimed is:
 1. A securement device for stabilizing a catheterassembly, comprising: a retainer configured to receive a portion of thecatheter assembly; an anchor pad comprising a top layer coupled to theretainer and a bottom layer comprising an adhesive; and a release liner,comprising: a first portion adhered to the bottom layer of the anchorpad; and a second portion coupled to the first portion along an inneredge of the first portion, wherein the second portion: is folded underthe first portion, extends laterally beyond an outer edge of the firstportion, and includes a clasping feature configured to releasably securethe second portion to the anchor pad.
 2. The securement device accordingto claim 1, wherein the clasping feature comprises a flap created by apartial cut into the second portion extending laterally beyond an outeredge of the first portion of the release liner.
 3. The securement deviceaccording to claim 2, wherein an outer edge of the anchor pad has anindented portion, and wherein the flap is positioned in the secondportion to releasably couple the second portion to the indented portionof the anchor pad.
 4. The securement device according to claim 1,wherein the clasping feature comprises an aperture in the first portionof the release liner, the aperture permitting the second portion of therelease liner to contact the adhesive layer through the aperture.
 5. Thesecurement device according to claim 1, wherein the top layer of theanchor pad comprises a fabric layer and a foam layer under the fabriclayer, and wherein the adhesive is disposed on at least a portion of thefoam layer.
 6. The securement device according to claim 1, furthercomprising a protective pad nested in a central portion of the anchorpad along a proximal edge of the anchor pad, the protective padincluding an aperture configured to receive the catheter assemblytherethrough.
 7. The securement device according to claim 6, wherein theprotective pad comprises a tear line disposed from the aperture to thecentral portion of the anchor pad, the tear line configured toselectively release the protective pad from the securement device. 8.The securement device according to claim 7, wherein the protective padhas a thickness equivalent to a thickness of the anchor pad.
 9. Thesecurement device according to claim 1, wherein the catheter assemblyincludes a catheter selected from the group consisting of a midlinecatheter, a dialysis catheter, a central venous catheter (“CVC”), aperipherally inserted central catheter (“PICC”), and a peripherallyinserted venous catheter (“PIV”).
 10. The securement device according toclaim 1, wherein the anchor pad comprises a first anchor pad and asecond anchor pad separated from the first anchor pad by a gap, andwherein the retainer comprises: a retainer body defining a channelaligned with the gap between the first anchor pad and the second anchorpad; a first mounting wing extending from a first side of the retainerbody, the first mounting wing coupled to the first anchor pad; and asecond mounting wing extending from a second side of the retainer body,the second mounting wing coupled to the second anchor pad.
 11. Thesecurement device according to claim 10, wherein the release linercomprises a first release liner coupled to the first anchor pad, and asecond release liner coupled to the second anchor pad.
 12. Thesecurement device according to claim 10, wherein each of the firstmounting wing and the second mounting wing includes a channel configuredto impart malleable characteristics.
 13. The securement device accordingto claim 12, wherein a thickness of the channel is in a range between0.010 in. and 0.020 in.
 14. The securement device according to claim 10,wherein the retainer is configured to mitigate rocking or pistoning ofthe catheter assembly.
 15. The securement device according to claim 10,wherein the retainer body includes a window to permit viewing of thecatheter assembly when disposed in the channel to verify properalignment of the catheter assembly in the channel.
 16. The securementdevice according to claim 1, wherein the retainer body is formed of atransparent, translucent, or semi-translucent material.